ICH Stability Studies

We offer comprehensive and cost-effective stability management, in accordance with GMP and ICH guidelines, providing a quality service meeting your specific storage and testing needs.

The long term stability of drug products (and other healthcare related products) is key to its quality, efficacy, safety and commercialisation. The stability of a product can be assessed in many ways e.g. physical stability (e.g. tablet crumbling, precipitation, viscosity), chemical (e.g. API degradation) or microbiological.

It is therefore vital to carry out stability studies that conform to ICH requirements and that challenge your prototypes and products in a range of environments.

Stability Storage

Our pharmaceutical stability services include a range of monitored temperature, humidity, and light stability storage cabinets which comply with ICH Guidelines, covering requirements for climatic zones I to IV.

Our stability storage conditions:

-80°C and -20°C

5°C

25°C/60%RH

30°C/65%RH

30°C/75%RH and 40°C/75%RH

We can store Schedule I to V controlled drugs and low temperature storage is available. In addition, we are able to set up non-standard temperature/humidity conditions upon request.

Our storage facilities are secure, fully validated and maintained and are 21CFR compliant monitored 24 hours a day, with a dedicated out of hours response team on call in case of emergency.

Whether you require storage only, or in combination with in-house analytical testing, we can tailor our stability service to meet your needs.

Stability Testing

We have a vast range of analytical techniques under the general banners of chemical, microbiological and physical testing that can be used to assess the stability of your product and its packaging in accordance with GMP requirements. We have experience in the development of pharmaceutical stability indicating methods, including photostability and other stress conditions. From protocol preparation to the issue of final reports, we offer comprehensive project management, plus advice and support.

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